Trial Outcomes & Findings for Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults (NCT NCT02261961)

NCT ID: NCT02261961

Last Updated: 2021-09-28

Results Overview

The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: change from baseline at 1 week post-vaccine
• Results posted on: 2021-09-28

Participant Flow

59 consented but only 44 randomized due to 15 either being excluded or withdrawal prior to randomization

Participant milestones

Measure	Nutritional Supplement Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 weeks.	Placebo Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.
Overall Study STARTED	22	22
Overall Study COMPLETED	13	20
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults

Baseline characteristics by cohort

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a post-training Follow-up	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approx 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approx 12 wks and undergo a Post-training Follow-up	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 4.8 • n=5 Participants	69.1 years STANDARD_DEVIATION 5.0 • n=7 Participants	69.2 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Leg Press	486.7 pounds STANDARD_DEVIATION 112.1 • n=5 Participants	519.3 pounds STANDARD_DEVIATION 130.6 • n=7 Participants	499.5 pounds STANDARD_DEVIATION 118.8 • n=5 Participants
Knee Curl	135.7 pounds STANDARD_DEVIATION 37.1 • n=5 Participants	128.2 pounds STANDARD_DEVIATION 26.5 • n=7 Participants	130.9 pounds STANDARD_DEVIATION 30.7 • n=5 Participants
Knee Extension	136.7 pounds STANDARD_DEVIATION 37.1 • n=5 Participants	132.3 pounds STANDARD_DEVIATION 37.9 • n=7 Participants	134.0 pounds STANDARD_DEVIATION 37.1 • n=5 Participants
Muscle Size	144.5 centimeters squared STANDARD_DEVIATION 22.2 • n=5 Participants	139.1 centimeters squared STANDARD_DEVIATION 21.0 • n=7 Participants	141.2 centimeters squared STANDARD_DEVIATION 21.3 • n=5 Participants
Tetanus Antibody Levels	4.3 units per ml STANDARD_DEVIATION 2.1 • n=5 Participants	3.7 units per ml STANDARD_DEVIATION 2.5 • n=7 Participants	3.9 units per ml STANDARD_DEVIATION 2.3 • n=5 Participants
Pertussis Antibody Levels	48.8 units per ml STANDARD_DEVIATION 32.9 • n=5 Participants	59.7 units per ml STANDARD_DEVIATION 41.2 • n=7 Participants	55.4 units per ml STANDARD_DEVIATION 38.0 • n=5 Participants
Diptheria Antibody Levels	0.6 units per ml STANDARD_DEVIATION 0.7 • n=5 Participants	0.7 units per ml STANDARD_DEVIATION 1.0 • n=7 Participants	0.7 units per ml STANDARD_DEVIATION 0.8 • n=5 Participants

PRIMARY outcome

Timeframe: change from baseline at 1 week post-vaccine

The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)	63.1 units per ml Standard Deviation 39.7	63.2 units per ml Standard Deviation 40.7

PRIMARY outcome

Timeframe: change from baseline at 2 weeks post-vaccine

The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)	159.2 units per ml Standard Deviation 130.7	216.7 units per ml Standard Deviation 240.1

PRIMARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of C-Reactive Protein	0.34 mg/L Standard Deviation 1.52	-3.96 mg/L Standard Deviation 10.05

PRIMARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.

Outcome measures

Measure	Nutritional Supplement n=9 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=10 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)	16.01 percent change Standard Deviation 49.36	-8.54 percent change Standard Deviation 25.70

PRIMARY outcome

Timeframe: change from baseline at completion of exercise training phase (12 weeks)

The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Strength After Exercise Training for 12 Weeks	195.4 pounds Standard Deviation 54.4	182.9 pounds Standard Deviation 45.7

SECONDARY outcome

Timeframe: change from baseline at 1 week post-vaccine

The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)	5.6 units per ml Standard Deviation 2.4	4.1 units per ml Standard Deviation 2.6

SECONDARY outcome

Timeframe: change from baseline at 2 weeks post-vaccine

The change in plasma antibody concentration for response to the tetanus antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)	8.6 units per ml Standard Deviation 3.7	8.2 units per ml Standard Deviation 5.1

SECONDARY outcome

Timeframe: change from baseline at 1 week post-vaccine

The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)	1.1 units per ml Standard Deviation 1.2	1.1 units per ml Standard Deviation 1.4

SECONDARY outcome

Timeframe: change from baseline at 2 weeks post-vaccine

The change in plasma antibody concentration for response to the diptheria antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)	2.1 units per ml Standard Deviation 1.6	1.7 units per ml Standard Deviation 1.5

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The number of muscle macrophages per myofiber will be counted for resting muscle collected before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=9 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=10 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Number of Muscle Macrophages Per Myofiber (Resting)	6.89 percent change Standard Deviation 21.99	42.42 percent change Standard Deviation 51.74

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training phase (12 weeks)

The change in size of the thigh muscle group after exercise training will be measured as the difference in cross-sectional area based on CT scan before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Size After Exercise Training for 12 Weeks	155.8 centimeters squared Standard Deviation 24.1	146.4 centimeters squared Standard Deviation 22.6

SECONDARY outcome

Timeframe: difference between baseline and time point one of de-training follow-up period (week 16)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Strength at Week 16 of the Post-Training Period	175.5 pounds Standard Deviation 50.0	162.9 pounds Standard Deviation 34.5

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in balance ability after exercise training will be measured as the difference in Berg Balance Scale (Min 0, Max 56, Higher is Better) score between before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Balance After Exercise Training for 12 Weeks	0.54 score on a scale Standard Deviation 1.27	0.79 score on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: difference between time of training completion and time point two of de-training follow-up period (26 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period	0.08 score on a scale Standard Deviation 0.49	0.05 score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: difference between time of training completion and time point one of de-training follow-up period (week 16)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in balance based on the Berg Balance Scale (Min 0, Max 56, Higher is Better) score will be measured during a follow-up period lacking exercise after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Balance at Week 16 of the Post-Training Period	-0.08 score on a scale Standard Deviation 0.49	0.11 score on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in walking ability after exercise training will be measured using the six minute walk test, i.e. the distance the participant can walk without shortness of breath in six minutes.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Walking Ability After Exercise Training for 12 Weeks	18.03 meters Standard Deviation 31.74	22.25 meters Standard Deviation 40.91

SECONDARY outcome

Timeframe: difference between end of training and time point one of de-training follow-up period (week 16)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Walking Ability at Week 16 of the Post-Training Period	-13.62 meters Standard Deviation 38.91	-29.02 meters Standard Deviation 55.89

SECONDARY outcome

Timeframe: difference between end of training and time point two of de-training follow-up period (week 26)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in walking ability based on the six-minute walk test will be measured during a follow-up period lacking exercise after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Walking Ability at Week 26 of the Post-Training Period	1.34 meters Standard Deviation 38.24	-20.85 meters Standard Deviation 52.33

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in gait speed ability after exercise training will be measured as the difference in habitual walking speed for 10 meters before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Gait Speed After Exercise Training for 12 Weeks	0.04 meters per second Standard Deviation 0.11	0.05 meters per second Standard Deviation 0.14

SECONDARY outcome

Timeframe: difference between after training and time point one of de-training follow-up period (week 16)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Gait Speed at Week 16 of the Post-Training Period	-0.02 meters per second Standard Deviation 0.10	-0.03 meters per second Standard Deviation 0.14

SECONDARY outcome

Timeframe: difference between after training and time point two of de-training follow-up period (week 26)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in habitual walking speed over 10 meters will be measured as the difference between values at the end of the training program and time points during a follow-up period lacking exercise.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Gait Speed During at Week 26 of the Post-Training Period	0.04 meters per second Standard Deviation 0.13	0.03 meters per second Standard Deviation 0.14

SECONDARY outcome

Timeframe: difference between baseline and time point two of de-training follow-up period (week 26)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in size of the thigh muscle group during the post-training period will be measured as the difference in cross-sectional area based on CT scan at the end of the training program and at the end of study participation.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Size at Week 26 of the Post-Training Period	143.6 centimeters squared Standard Deviation 24.4	140.5 centimeters squared Standard Deviation 19.9

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Timed Up and Go After Exercise Training for 12 Weeks	-0.22 seconds Standard Deviation 0.65	-0.26 seconds Standard Deviation 0.71

SECONDARY outcome

Timeframe: difference between after training and time point one of de-training follow-up period (week 16)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Timed Up and Go at Week 16 of the Post-Training Period	0.33 seconds Standard Deviation 1.12	0.18 seconds Standard Deviation 0.77

SECONDARY outcome

Timeframe: difference between after training and time point two of de-training follow-up period (week 26)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in time required to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down will be measured as the difference between time points at the end of the training program and during the post-training period.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Timed Up and Go at Week 26 of the Post-Training Period	0.14 seconds Standard Deviation 1.18	-0.15 seconds Standard Deviation 0.65

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The muscle concentration of interleukin-1 beta will be measured before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=7 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=7 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Percent Change in Resting Muscle Concentration of Interleukin-1 Beta	58.00 percent change Standard Deviation 172.57	40.93 percent change Standard Deviation 148.80

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in the muscle concentration of interleukin-1 beta before and one hour after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.

Outcome measures

Measure	Nutritional Supplement n=7 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=7 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise)	110.52 percent change Standard Deviation 424.92	-89.70 percent change Standard Deviation 2744.35

SECONDARY outcome

Timeframe: percent change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in resting muscle atrophy gene MURF expression will be measured before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=18 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Resting Muscle Atrophy Gene MURF Expression	20.98 percent change Standard Deviation 99.61	148.17 percent change Standard Deviation 325.87

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in resting muscle atrophy gene MURF expression will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=17 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise)	38.69 percent change Standard Deviation 224.53	-76.98 percent change Standard Deviation 423.64

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in resting muscle Protein Kinase B will be measured before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=9 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=9 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Resting Muscle Protein Kinase B	78.15 percent change Standard Deviation 187.21	51.24 percent change Standard Deviation 112.35

SECONDARY outcome

Timeframe: change from baseline at 2 weeks of treatment

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in muscle Protein Kinase B will be measured before and 72 hours after a single bout of exercise completed before and after two weeks of treatment with supplement or placebo.

Outcome measures

Measure	Nutritional Supplement n=9 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=9 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Protein Kinase B (Post-acute Exercise)	-27.24 percent change Standard Deviation 127.78	9.48 percent change Standard Deviation 85.32

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in the satellite cell content of muscle will be measured as the difference in the number of satellite cells in muscle before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=16 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks	18.24 percent change Standard Deviation 48.93	9.96 percent change Standard Deviation 40.72

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in the myonuclear content of muscle will be measured as the difference in the number of myonuclei in muscle before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=16 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Number of Myonuclei After Exercise Training for 12 Weeks	6.88 percent change Standard Deviation 36.99	20.28 percent change Standard Deviation 27.65

SECONDARY outcome

Timeframe: change from baseline at completion of exercise training (12 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to insufficient specimen.

The change in the muscle fiber size will be measured as the difference in fiber size before and after completion of the exercise training program.

Outcome measures

Measure	Nutritional Supplement n=10 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=15 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Fiber Size After Exercise Training for 12 Weeks	35.26 percent change Standard Deviation 51.59	47.28 percent change Standard Deviation 54.87

OTHER_PRE_SPECIFIED outcome

Timeframe: at completion of the exercise training program (15 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.

Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks	29.25 Units/L Standard Deviation 7.79	26.37 Units/L Standard Deviation 7.78

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of the exercise training program (15 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.

Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks	24.83 Units/L Standard Deviation 13.90	24.53 Units/L Standard Deviation 13.21

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of the exercise training program (15 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a clinical lab error and a participant not completing entire study.

Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=12 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks	20.40 ratio Standard Deviation 5.22	13.35 ratio Standard Deviation 3.98

OTHER_PRE_SPECIFIED outcome

Timeframe: end of study (42 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Aspartate Aminotransferase After 42 Weeks of Product Consumption	28.31 Units/L Standard Deviation 8.83	27.16 Units/L Standard Deviation 9.50

OTHER_PRE_SPECIFIED outcome

Timeframe: end of study (42 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Alanine Aminotransferase After 42 Weeks of Product Consumption	22.38 Units/L Standard Deviation 8.49	25.32 Units/L Standard Deviation 10.11

OTHER_PRE_SPECIFIED outcome

Timeframe: end of study (42 weeks)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After 42 Weeks of Product Consumption	20.98 ratio Standard Deviation 9.10	14.44 ratio Standard Deviation 4.95

OTHER_PRE_SPECIFIED outcome

Timeframe: difference between baseline and time point two of de-training follow-up period (week 26)

Population: The overall number of participants analyzed was less than the total number of participants due to a participant not completing entire study.

The change in muscle strength (one-repetition maximum for knee extension) after completion of the exercise training program will be measured during a follow-up period lacking exercise.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Change in Muscle Strength at Week 26 of the Post-Training Period	171.2 pounds Standard Deviation 50.6	165.0 pounds Standard Deviation 36.3

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Plasma aspartate aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Aspartate Aminotransferase	26.62 Units/L Standard Deviation 7.52	27.55 Units/L Standard Deviation 10.97

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Population: The overall number of participants analyzed was less than the total number of participants due to clinical lab error.

Plasma Alanine Aminotransferase will be measured as a safety indicator of liver function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=19 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Plasma Concentration of Alanine Aminotransferase	21.54 Units/L Standard Deviation 6.24	27.42 Units/L Standard Deviation 16.68

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Plasma blood urea nitrogen and creatinine will be measured as a safety indicator of kidney function at baseline, after completion of the exercise training program, and at the end of the study.

Outcome measures

Measure	Nutritional Supplement n=13 Participants Subjects in the supplement group will consume Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: B	Placebo n=20 Participants Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up
Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine	14.06 ratio Standard Deviation 3.75	14.52 ratio Standard Deviation 5.18

Adverse Events

Nutritional Supplement

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nutritional Supplement n=22 participants at risk Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training.	Placebo n=22 participants at risk Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approx 26 wks after completion of the ex training.
Cardiac disorders SAE	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Cardiac disorders Cardiovascular Event	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	9.1% 2/22 • Number of events 2 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Gastrointestinal disorders colon polyps	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Hepatobiliary disorders gallstones	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	9.1% 2/22 • Number of events 2 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Product Issues lost name and address	9.1% 2/22 • Number of events 2 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Musculoskeletal and connective tissue disorders knee surgery	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
General disorders unknown surgery	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	0.00% 0/22 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.

Other adverse events

Measure	Nutritional Supplement n=22 participants at risk Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training.	Placebo n=22 participants at risk Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation. TDAP: Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo Acute Resistance Exercise: Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle Resistance Exercise Training: Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks. Post-training Follow-up: Both arms will continue to receive treatment with supplement or placebo for approx 26 wks after completion of the ex training.
General disorders biopsy pain or bruise	9.1% 2/22 • Number of events 2 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
General disorders bodily wound	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
General disorders cold, flu, or infection	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	22.7% 5/22 • Number of events 5 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Gastrointestinal disorders gastrointestinal distress	4.5% 1/22 • Number of events 1 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Musculoskeletal and connective tissue disorders musculoskeletal soreness, strain, or pain	18.2% 4/22 • Number of events 7 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	31.8% 7/22 • Number of events 11 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.
Skin and subcutaneous tissue disorders skin irritation, rash, or numbness	13.6% 3/22 • Number of events 3 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.	31.8% 7/22 • Number of events 7 • Adverse event data was collected from participants at every interaction (in-person, phone contact, or monitoring of electronic health record prior to in-person appointment) from the point of informed consent until 30 days after participant completion of study, which averaged 62 weeks total.

Additional Information

Richard Dennis

Central Arkansas Veterans Healthcare System

Phone: 501-257-5583

Email: richard.dennis2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place